Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT02260518
Eligibility Criteria:
Inclusion Criteria:
* White or African American woman
* Overweight or obese (prepregnancy BMI: 25-45 kg/m2)
* ≤ 16 wks gestation at screening
* Age 18-44 years
* No plan to move out of the greater Columbia area in next 18 months
* Regular and consistent telephone access
* Availability for telephone calls
* Willing to accept random assignment
Exclusion Criteria:
* Uncontrolled hypertension
* Fetal anomaly
* Taking insulin for diabetes
* Uncontrolled or untreated thyroid disease
* Mental health or substance-abuse hospitalization in last 6 months
* Multiple gestation
* Persistent bleeding in the first trimester
* History of more than 3 miscarriages
* History of an eating disorder or current eating disorder
* History of an incompetent cervix
* Physical disability that prevents exercise
* Told by health care provider not to exercise
* Any other medical conditions that might be a contraindication to exercise or dietary change
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT02260518
Study Brief:
Protocol Section:
NCT02260518